Systems, devices, and methods for revising or supplementing rom-based rf commands

ABSTRACT

Systems, devices, and methods are provided that enable the revision of RF command handling software stored in ROM, and that enable to supplementation of RF command handling software stored in ROM. Examples of the systems, devices, and methods make use of a lookup data structure stored within writable non-volatile memory.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/662,728, filed Oct. 24, 2019, which is a continuation ofU.S. patent application Ser. No. 14/945,149, filed Nov. 18, 2015, nowU.S. Pat. No. 10,497,473, which claims priority to and the benefit ofU.S. Provisional Patent Application Ser. No. 62/081,851, filed Nov. 19,2014, all of which are incorporated by reference herein in theirentireties for all purposes.

FIELD

The subject matter described herein relates to systems, devices, andmethods for revising the execution of RF commands stored in ROM and/orsupplementing the RF commands stored in ROM, for example, with respectto medical devices used in an analyte monitoring environment.

BACKGROUND

The detection and/or monitoring of analyte levels, such as glucose,ketones, lactate, oxygen, hemoglobin A1C, or the like, can be vitallyimportant to the health of an individual having diabetes. Diabeticsgenerally monitor their glucose levels to ensure that they are beingmaintained within a clinically safe range, and may also use thisinformation to determine if and/or when insulin is needed to reduceglucose levels in their bodies or when additional glucose is needed toraise the level of glucose in their bodies.

Growing clinical data demonstrates a strong correlation between thefrequency of glucose monitoring and glycemic control. Despite suchcorrelation, many individuals diagnosed with a diabetic condition do notmonitor their glucose levels as frequently as they should due to acombination of factors including convenience, testing discretion, painassociated with glucose testing, and cost. Accordingly, needs forimproved analyte monitoring systems, devices, and methods exist.

SUMMARY

A number of systems have been developed for the automatic monitoring ofthe analyte(s), like glucose, in a bodily fluid of a user, such as inthe blood, interstitial fluid (“ISF”), dermal fluid, or in otherbiological fluid. Some of these systems include a sensor that can be atleast partially positioned “in vivo” within the user, e.g.,transcutaneously, subcutaneously, or dermally, to make contact with theuser's bodily fluid and sense the analyte levels contained therein.These systems are thus referred to as in vivo analyte monitoringsystems.

The sensor is generally part of a sensor control device that resides on(or in) the body of the user and contains the electronics and powersource that enable and control the analyte sensing. The sensor controldevice, and variations thereof, can be referred to as a “sensor controlunit,” an “on-body electronics” device or unit, an “on-body” device orunit, or a “sensor data communication” device or unit, to name a few.

The analyte data sensed with the sensor control device can becommunicated to a separate device that can process and/or display thatsensed analyte data to the user in any number of forms. This device, andvariations thereof, can be referred to as a “reader device” (or simply a“reader”), “handheld electronics” (or a handheld), a “portable dataprocessing” device or unit, a “data receiver,” a “receiver” device orunit (or simply a receiver), or a “remote” device or unit, to name afew. The reader device can be a dedicated use device, a smart phone, atablet, a wearable electronic device such as a smart glass device, orothers.

In vivo analyte monitoring systems can be broadly classified based onthe manner in which data is communicated between the reader device andthe sensor control device. One type of in vivo system is a “ContinuousAnalyte Monitoring” system (or “Continuous Glucose Monitoring” system),where data can be broadcast from the sensor control device to the readerdevice continuously without prompting, e.g., in an automatic fashionaccording to a broadcast schedule. Another type of in vivo system is a“Flash Analyte Monitoring” system (or “Flash Glucose Monitoring” systemor simply “Flash” system), where data can be transferred from the sensorcontrol device in response to a scan or request for data by the readerdevice, such as with a Near Field Communication (NFC) or Radio FrequencyIdentification (RFID) protocol.

In vivo analyte monitoring systems can be differentiated from “in vitro”systems that contact a biological sample outside of the body (or rather“ex vivo”) and typically include a meter device that has a port forreceiving an analyte test strip carrying bodily fluid of the user, whichcan be analyzed to determine the user's blood sugar level.

Both in vitro and in vivo systems can utilize locally stored software toperform a number of measurement, data collection, data analysis,communication, and other application related functions. This softwarecan be stored, at least in part, in non-volatile memory within thedevice. One such non-volatile memory is read-only memory (ROM), whichprovides advantages in cost, power efficiency, and reliability, amongothers. Software that is stored in ROM is electrically and physicallydesigned into the memory layout during the semiconductor manufacturingprocess, i.e., the software is permanently coded in the ROM. Thesoftware therefore cannot be altered after the semiconductor device hasbeen manufactured. The introduction of a software revision can only beaccomplished by redesigning the semiconductor device, producing arevised layout, assembling new photolithography masks, and fabricatingentirely new semiconductor chips, which is a lengthy and expensiveprocess. It may also require those semiconductor devices that werealready assembled to be discarded.

However, analyte monitoring applications can be complex and continuallyevolving as ever more research and resources are devoted to improvingthe health and lifestyle of the patients. These applications are alsosubject to governmental regulations that can be introduced, changed, orinterpreted in ways that require modifications to the operation of theanalyte monitoring devices. The introduction of revisions to ROM-basedsoftware code are therefore a significant concern.

Described herein are a number of example embodiments of systems,devices, and methods that can allow the providers of analyte monitoringdevices to supplement, disable, or revise existing RF command handlingsoftware that is, e.g., hardcoded within the ROM of a semiconductordevice, without requiring the fabrication of new devices altogether.Many of these example embodiments are described with respect to ananalyte monitoring environment, but can also be applied in otherenvironments without limitation (both within and outside of thehealthcare industry).

Other systems, devices, methods, features and advantages of the subjectmatter described herein will be or will become apparent to one withskill in the art upon examination of the following figures and detaileddescription. It is intended that all such additional systems, devices,methods, features and advantages be included within this description, bewithin the scope of the subject matter described herein, and beprotected by the accompanying claims. In no way should the features ofthe example embodiments be construed as limiting the appended claims,absent express recitation of those features in the claims.

BRIEF DESCRIPTION OF THE FIGURES

The details of the subject matter set forth herein, both as to itsstructure and operation, may be apparent by study of the accompanyingfigures, in which like reference numerals refer to like parts. Thecomponents in the figures are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles of the subject matter.Moreover, all illustrations are intended to convey concepts, whererelative sizes, shapes and other detailed attributes may be illustratedschematically rather than literally or precisely.

FIG. 1 is a high level diagram depicting an example embodiment of ananalyte monitoring system for real time analyte (e.g., glucose)measurement, data acquisition and/or processing.

FIGS. 2A-C are block diagrams depicting example embodiments of a sensorcontrol device.

FIG. 3A is a flow diagram depicting an example embodiment of a method ofdetermining the appropriate RF command handler to be used in executing areceived RF command.

FIG. 3B is a conceptual block diagram depicting an example embodiment ofa sensor control device at various stages during execution of an examplemethod of determining the appropriate RF command handler to be used inexecuting a received RF command.

FIGS. 4A-C are block diagrams depicting example embodiments of a lookupdata structure in human readable form.

FIG. 5 is a flow diagram depicting an example embodiment of a method ofproducing a sensor control device having software stored in ROM andrevised or updated RF command handling software stored in writablenon-volatile memory.

DETAILED DESCRIPTION

Before the present subject matter is described in detail, it is to beunderstood that this disclosure is not limited to the particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

An example embodiment of an in vivo analyte monitoring system 100 withwhich the embodiments described herein can be used is depicted in theillustrative view of FIG. 1. Here, system 100 includes a sensor controldevice 102 and a reader device 120 that can communicate with each otherover a local wireless communication path (or link) 140, which can beuni-directional or bi-directional. The communications sent across link140 contain digital messages in a frame format (which includes packets)and can be based on a Near Field Communication (NFC) protocol (includingan RFID protocol), Bluetooth or Bluetooth Low Energy (BTLE) protocol,Wi-Fi protocol, proprietary protocol, or others. Reader device 120 isalso capable of wired, wireless, or combined communication overcommunication paths (or links) 141 and 142 with other systems ordevices, such as a computer system 170 (e.g., a server for a website, apersonal computer, a tablet, and the like) or cloud-based storage 190.

Other embodiments of sensor control device 102 and reader device 120, aswell as other components of an in vivo-based analyte monitoring systemthat are suitable for use with the system, device, and methodembodiments set forth herein, are described in U.S. Patent ApplicationPubl. No. 2011/0213225 (the '225 Publication), which is incorporated byreference herein in its entirety for all purposes.

Sensor control device 102 can include a housing 103 containing in vivoanalyte monitoring circuitry and a power source 260 (shown in FIGS.2A-B). Referring to FIG. 1, the in vivo analyte monitoring circuitry iselectrically coupled with an analyte sensor 104 that extends through apatch 105 and projects away from housing 103. An adhesive layer (notshown) can be positioned at the base of patch 105 for attachment to askin surface of the user's body. Other forms of attachment to the bodymay be used, in addition to or instead of adhesive. Sensor 104 isadapted to be at least partially inserted into the body of the user,where it can make contact with the user's bodily fluid and, onceactivated, used with the in vivo analyte monitoring circuitry to measureand collect analyte-related data of the user. Generally, sensor controldevice 102 and its components can be applied to the body with amechanical applicator 150 in one or more steps, as described in theincorporated '225 Publication, or in any other desired manner.

In other embodiments, system 100 can include wholly implantable sensorsand wholly implantable assemblies in which a single assembly includingthe analyte sensor and electronics are provided in a sealed housing(e.g., hermetically sealed biocompatible housing) for implantation in auser's body for monitoring one or more physiological parameters.

After activation, sensor control device 102 can wirelessly communicatethe collected analyte data (such as, for example, data corresponding tomonitored analyte level and/or monitored temperature data, and/or storedhistorical analyte related data) to reader device 120 where, in certainembodiments, it can be algorithmically processed into datarepresentative of the analyte level of the user and then displayed tothe user and/or otherwise incorporated into a diabetes monitoringregime.

As shown in FIG. 1, reader device 120 includes a display 122 to outputinformation to the user and/or to accept an input from the user (e.g.,if configured as a touch screen), and one optional user interfacecomponent 121 (or more), such as a button, actuator, touch sensitiveswitch, capacitive switch, pressure sensitive switch, jog wheel or thelike. Reader device 120 can also include one or more data communicationports 123 for wired data communication with external devices such ascomputer system 170 (described below). Reader device 120 may alsoinclude an in vitro analyte meter, including an in vitro test strip port(not shown) to receive an in vitro analyte test strip for performing invitro analyte measurements.

Computer system 170 can be used by the user or a medical professional todisplay and/or analyze the collected analyte data with an informaticssoftware program. Computer system 170 may be a personal computer, aserver terminal, a laptop computer, a tablet, or other suitable dataprocessing device, and can be (or include) software for data managementand analysis and communication with the components in analyte monitoringsystem 100.

The processing of data and the execution of software within system 100can be performed by one or more processors of reader device 120,computer system 170, and/or sensor control device 102. For example, rawdata measured by sensor 104 can be algorithmically processed into avalue that represents the analyte level and that is readily suitable fordisplay to the user, and this can occur in sensor control device 102, orit can occur in reader device 120 or computer system 170 after receiptof the raw data from sensor control device 102. This and any otherinformation derived from the raw data can be displayed in any of themanners described above (with respect to display 122) on any displayresiding on any of sensor control device 102, reader device 120, orcomputer system 170. The information may be utilized by the user todetermine any necessary corrective actions to ensure the analyte levelremains within an acceptable and/or clinically safe range.

As discussed above, reader device 120 can be a mobile communicationdevice such as, for example, a Wi-Fi or internet enabled smartphone,tablet, or personal digital assistant (PDA). Examples of smartphones caninclude, but are not limited to, those phones based on a WINDOWSoperating system, ANDROID operating system, IPHONE operating system,PALM WEBOS, BLACKBERRY operating system, or SYMBIAN operating system,with data network connectivity functionality for data communication overan internet connection and/or a local area network (LAN).

Reader device 120 can also be configured as a mobile smart wearableelectronics assembly, such as an optical assembly that is worn over oradjacent to the user's eye (e.g., a smart glass or smart glasses, suchas GOOGLE GLASSES). This optical assembly can have a transparent displaythat displays information about the user's analyte level (as describedherein) to the user while at the same time allowing the user to seethrough the display such that the user's overall vision is minimallyobstructed. The optical assembly may be capable of wirelesscommunications similar to a smartphone. Other examples of wearableelectronics include devices that are worn around or in the proximity ofthe user's wrist (e.g., a watch, etc.), neck (e.g., a necklace, etc.),head (e.g., a headband, hat, etc.), chest, or the like.

FIG. 2A is a block diagram depicting an example embodiment of sensorcontrol device 102 having analyte sensor 104 and sensor electronics 250(including analyte monitoring circuitry). Although any number of chipscan be used, here the majority of sensor electronics 250 areincorporated on a single semiconductor chip 251 that can be a customapplication specific integrated circuit (ASIC). Shown within ASIC 251are certain high-level functional units, including an analog front end(AFE) 252, power management (or control) circuitry 254, processor 256,and communication circuitry 258 for communications between device 102and reader device 120. In this embodiment, both AFE 252 and processor256 are used as analyte monitoring circuitry, but in other embodimentseither circuit (or a portion thereof) can perform the analyte monitoringfunction. Processor 256 can include one or more processors (e.g., twoprocessors acting in concert), microprocessors, controllers, and/ormicrocontrollers.

A non-transitory memory 253 is also included within ASIC 251 and can beshared by the various functional units present within ASIC 251, or canbe distributed amongst two or more of them. Memory 253 can be volatileand/or non-volatile memory. In this embodiment, ASIC 251 is coupled withpower source 260, e.g., a coin cell battery. AFE 252 interfaces with invivo analyte sensor 104 and receives measurement data therefrom,conditions the data signal, and outputs the data signal to processor 256in analog form, which in turn uses an analog-to-digital converter (ADC)to convert the data to digital form (not shown) and then processes thedata to arrive at the end-result analyte discrete and trend values, etc.

This data can then be provided to communication circuitry 258 forsending, by way of antenna 261, to reader device 120 (not shown) wherefurther processing can be performed. Communication circuitry 258 canoperate according to any of the wireless (e.g., NFC, Bluetooth, andWi-Fi) communication protocols described herein, or any other desiredcommunication protocol, depending on the selected manner ofcommunication with reader device 120. In other embodiments communicationcircuitry 158 can be adapted for wired communication.

FIG. 2C is similar to FIG. 2B but instead includes two discretesemiconductor chips 262 and 263, which can be packaged together orseparately. Here, AFE 252 is resident on ASIC 262. Processor 256 isintegrated with power management circuitry 254 and communicationcircuitry 258 on chip 263. In one example embodiment, AFE 252 iscombined with power management circuitry 254 and processor 256 on onechip, while communication circuitry 258 is on a separate chip. Inanother example embodiment, both AFE 252 and communication circuitry 258are on one chip, and processor 256 and power management circuitry 254are on another chip. Other chip combinations are possible, includingthree or more chips, each bearing responsibility for the separatefunctions described, or sharing one or more functions for fail-saferedundancy.

FIG. 2C is a block diagram depicting another embodiment of sensorcontrol device 102, which can be implemented as one or more ASICs. Aswith the embodiments described with respect to FIGS. 2A-B, an analytesensor 104, antenna 261, and a power source 260 are coupled with sensorelectronics 250, which again includes AFE 252, power managementcircuitry 254, processor 256, and communication circuitry 258. Here,sensor electronics 250 are shown with the non-transitory memory dividedinto both volatile and non-volatile memory units (or portions).Specifically, sensor electronics 250 includes ROM 230 (non-volatile),random access memory (RAM) 232 (volatile), and ferroelectric RAM (FRAM)234 (non-volatile). Other types of non-volatile memory can also be used,including, but not limited to, flash memory, magnetoresistive RAM(MRAM), erasable programmable read-only memory (e.g., EPROM or EEPROM),a hard disk, an optical disc, and a holographic memory.

In certain embodiments, part or all of the application software isstored within ROM 230, including the application (or other) softwareresponsible for processing or handling received RF commands. Asdescribed herein, revisions to the RF command handling software can bestored to FRAM 234 during the board assembly or test phase (i.e., afterfabrication and packaging of the semiconductor chips).

Also included with sensor electronics 250 is a serial interface 229. Incertain embodiments, serial interface 229 is for serial testing and canbe configured as a boundary scan interface linked to a boundary scanarchitecture that permits access to the internal circuitry of sensorelectronics 250 that may not otherwise be accessible after sensorelectronics 250 is assembled into a semiconductor package, or onto alarger printed circuit board (PCB), and the like. Serial interface 229can permit the writing of new software to electronics 250, such asreplacement code for code stored within ROM 230, as is described infurther detail herein.

In certain embodiments, the boundary scan architecture can be a JointTest Action Group (JTAG) architecture, or other architecture conformingto IEEE 1149.1 (Standard Test Access Port and Boundary ScanArchitecture), although the boundary scan architecture is not limited tosuch. In one embodiment where serial interface 229 is in a JTAGconfiguration (not shown), interface 229 includes four externallyaccessible inputs and/or outputs (e.g., pins, pads, or connectors, andthe like) that can be (or can be equivalent to) a Test Data In (TDI)input, a Test Data Out (TDO) output, a Test Clock (TCK) input, and aTest Mode Select (TMS) input. A Test Reset (TRST) can also optionally beincluded. TDI can be used for inputting any data or software (notnecessarily test related) into the device and TDO can be used foroutputting any data from the device. TCK can be used as a clock and TMScan be used to switch the architecture between various modes or statemachine states. Together they can permit the serial advancement of dataor software through a chain of internal registers (not shown) and intothe internal circuitry and memory as needed.

Sensor electronics 250 depicted in FIG. 2C can be implemented as onesingle semiconductor chip or as multiple chips located on one or morePCBs. If implemented as multiple chips, the functions provided by eachof AFE 252, power management circuitry 254, processor 256, communicationcircuitry 258, ROM 230, RAM 232, and FRAM 234 can be implemented onseparate chips or can be dispersed such that each resides on more thanone chip, or any combination readily recognized to those of ordinaryskill in the art.

All of the elements of FIGS. 2A-C (e.g., processor 256, AFE 252,communication circuitry 258, memory 253, ROM 230, FRAM 234, RAM 232,power management circuitry 254, sensor 104, serial interface 229) can beconfigured to communicate with every other element directly (e.g., via adedicated pathway or bus), indirectly (e.g., via one or more common orshared buses), or any combination of the two.

All or part of the RF command handling software for sensor controldevice 102 can be hardcoded, or permanently coded, within ROM 230 oranother type of non-volatile memory. The systems, devices, and methodsdescribed herein can provide an efficient, flexible, and/orcost-effective pathway to revising or supplementing that software.

Embodiments of these systems, devices, and methods will be describedwith respect to an example implementation, namely, the revision,replacement, or supplementation of RF command handling software residentwithin ROM 230 of a sensor control device 102 used in an in vivo analytemonitoring environment. However, these embodiments can likewise beapplied to other implementations, including, but not limited to: thosein which the RF command handling software is resident within anothertype of non-volatile memory other than ROM; devices other than sensorcontrol devices (e.g., readers, meters, etc.); in vitro analytemonitoring implementations, or hybrid implementations utilizing both invivo and in vitro functionality; and other implementations outside ofthe medical field. In other words, the systems, devices, and methodsdescribed herein can be used in many implementations other than that ofa sensor control device having ROM that is used in an in vivo analytemonitoring environment.

While not limited to such, the embodiments described are particularlysuitable to implementation on ASICs where reprogramming of the softwarecode and reconfiguration of the supporting hardware circuitry is muchmore difficult than in more flexible architectures, such asfield-programmable gate arrays (FPGAs), programmable logic orprogrammable logic devices (PLDs). With sufficient volume, custom chips,in the form of ASICs, offer a very attractive proposition. ASICs mayalso be used sometimes because they enable circuits to be made thatmight not be technically viable using other technologies. They may offerspeed and performance that would not be possible if discrete componentswere used. Conventional ASIC methodology relies on libraries ofso-called, “standard cells.” These libraries contain large numbers ofpre-designed circuits (basic building blocks) that can be selected,mixed, rearranged and and re-used for different customers orapplications. After the subset of cells is selected, they are frugallylaid-out in the IC circuit space, adjacent appropriate other blocks, andare interconnected to construct more complex circuits within theintegrated circuit in a space efficient (and therefore cost optimal)manner. Examples of digital ASIC standard cells include multi-BITadders, multipliers, multiplexers, decoders, and memory blocks (look-uptables). Examples of analog ASIC standard cells include amplifiers,comparators, analog-to-digital, and digital-to-analog converters. ASICsmay include mixed signal designs (ICs having both analog and digitalcircuitry on the same substrate).

In many embodiments, sensor control device 102 receives RF or wirelesscommands over communication path 140 from reader device 120. Thesecommands can instruct sensor control device 102 to take certain actions.Several examples include a command to activate the onboard sensor 104,to retrieve information about sensor 104 for authentication purposes, toread collected data values from memory, to sense an analyte level of theuser, and so forth.

FIG. 3A is a flow diagram depicting an example embodiment of a method300 performed by sensor control device 102 upon receiving an RF (orwireless) command. In many embodiments, method 300 can be coded insoftware either generally as part of the application program or as oneor more software functions, and can be executed by processor 256 (andits variants). In embodiments herein, the application program may bereferred to as application programming, application software or simplyas programming or software, all of which are meant to indicate what ismainly permanent programming that exists in a device and that includesthe numerous software functions.

FIG. 3B is an illustrative diagram depicting an example embodiment ofsensor control device 102 similar to that described with respect to FIG.2C but omitting certain components for ease of illustration. The diagramof FIG. 3B will be used in conjunction with that of FIG. 3A to describevarious stages of methods of processing the received RF command in adynamic fashion, where sensor control device 102 uses software notoriginally hardcoded within ROM 230 to allow for a revised procedure forhandling a particular RF command, or to allow for the handling of new RFcommands beyond those that the original code was written to handle. Theexample embodiments described with respect to FIGS. 3A-B can beimplemented with any embodiment of an analyte monitoring system 100described herein.

At 302, an RF command is received by antenna 261 and processed andvalidated by communication circuitry 258. The RF command can becontained within a field of an RF transmission formatted according tothe appropriate communication protocol (e.g., NFC, RFID, Bluetooth,Wi-Fi, etc.). The processing and validation of the received RF commandcan be performed by either hardware or software. If the RF command isvalid, then communication circuitry 258 will send an interrupt 351 (orother notification) to processor 256 at 304. If the RF command is notvalid then no further action is taken. Processor 256 can interpret theinterrupt with an interrupt handling function 354 and identify and callthe appropriate software function for managing further processing of thereceived RF command at 306.

In this and other embodiments, the software function (or set offunctions) that manages the further processing of the received RFcommands (e.g., locating the appropriate handler) is referred to as RFstack 358, and can be hardcoded within ROM 230. Processor 256 issues acall 355 to RF stack 358 as shown in FIG. 3B. RF stack 358 is shownwithin ROM 230 to denote its place of storage in this embodiment, butwould actually be executed by processor 256 during operation.

The term “function” is used broadly herein to encompass any programinstruction, or sequence of instructions, that performs a specific task.In many embodiments, the function will be named and/or stored in a knownlocation and the operating software will be capable of calling thatfunction by its name or location. Various computer languages refer tosoftware functions using different terminology such as routines,subroutines, procedures, methods, programs, subprograms, or callableunits, each of which are within the scope of the term “function” as usedherein. Likewise, the systems, devices, and methods described herein arenot limited to any particular programming language.

Each RF command can be processed or handled by one or more softwarefunctions. These functions are referred to herein as handlers. One ormore handlers can be stored in ROM 230 during fabrication and cannot bealtered once stored. These one or more handlers are shown as original RFcommand handlers 360 in FIG. 3B. The term “original” is used because RFcommand handlers 360 are stored in ROM 230 during the ROM fabricationitself.

One or more additional RF command handlers can be stored in writablememory during a later (or different) stage of the manufacturing process.These handlers are referred to as new RF command handlers 374 and arestored in FRAM 234 in the embodiment of FIG. 3B. New RF command handlers374 can be replacements for command handlers 360 (stored in ROM 230)that are revised to process a particular RF command in a differentmanner than was originally contemplated. Alternatively (oradditionally), new RF command handlers 374 can include the programmingto process new RF commands that the original sensor control device 102did not have the capability to handle. In either case, the embodimentsdescribed herein can allow the functionality of sensor control device102 to be altered without requiring new iterations of ROM 230 to bedesigned and fabricated, which saves numerous costs for themanufacturer.

In this context the terms “original” and “new” are used in a broadsense. The “original” RF command handler does not refer only to the veryfirst iteration of ROM 230 that was developed or built, but can alsorefer to any subsequent iteration of ROM 230 including the latest one.Likewise, the “new” RF command handler does not refer only to the newestcommand handler or to a command handler that was only recentlydeveloped, but also any version of an RF command handler regardless ofwhether it is an earlier version or has been in existence forsignificant amount of time. The terms are used primarily to convey adistinction between those RF command handlers that were hardcoded withinsensor control device 102 (i.e., original) and those RF command handlersthat, regardless of reason, are written into sensor control device 102to alter its functionality (i.e., new) from that provided solely by theoriginal RF command handlers.

Referring back to FIG. 3A, after RF stack 358 is called by processor 256at 306, RF stack 358 can reference a lookup data structure 370 stored inwritable memory (e.g., FRAM 234) to assist in locating the appropriateRF command handler for the received RF command at 308. The referencingof lookup data structure 370 is depicted conceptually by arrow 356 inFIG. 3B.

Lookup data structure 370 can include identifications of some or all ofthe RF commands executable by sensor control device 102 along withidentifications of their respective RF command handlers. An exampleembodiment of lookup data structure 370 is depicted in FIG. 4. In thisembodiment, lookup data structure 370 is arranged sequentially in memorysuch that an identifier for each command is followed by the identifierfor the handler responsible for executing that command. For example, theidentifier for a first command (command_001) is followed by theidentifier for the corresponding first command handler (handler_001) andthis pair is labeled 402-1. Immediately following pair 402-1 is a secondpair 402-2 that includes an identifier for a second command(command_002) and an identifier for the corresponding second commandhandler (handler_002). Lookup data structure 370 can include any number(N) of zero or more identifiers arranged in this fashion. Here, theultimate pair is indicated by 402-N.

The command identifiers (command_001, command_002, etc.) can be anystring of characters that is recognized within system 100 as identifyingthe RF command, e.g., an index, a name, or a memory pointer (e.g., anaddress). In some embodiments, the command identifier is a 16 bit numberthat can be represented by a string of four hexadecimal characters,e.g., 00A0, 1B2C, etc. Each of these command identifiers can be carriedwithin a field of the encoded received wireless transmission andextracted from the received wireless transmission during the validationprocess. Other character lengths can be used as well.

The extracted command identifier can then be subsequently passed to RFstack 358, which, after being called at 308 (FIG. 3A), can perform acompare or match process between that received command identifier andthose contained within lookup data structure 370 at 309. In theembodiment depicted in FIG. 4, RF stack 358 can proceed sequentiallythrough lookup data structure 370 and can compare the received commandidentifier with the first command identifier. If the identifiers do notmatch, then RF stack 358 will advance two memory locations to the secondcommand identifier and perform another compare. This process repeatsuntil a match is found or the end of lookup data structure 370 isreached. The embodiments herein are not limited to this type ofsequential marching through lookup data structure 370 and non-sequentialor partially sequential techniques can be used as well.

Referring back to FIG. 3A, if a match is found, then RF stack 358obtains the corresponding handler identifier for the matching commandidentifier at 310. In this embodiment, RF stack 358 will advance to theimmediate next memory location that contains the handler identifier forthe matching command. As with the command identifiers, the handleridentifiers (handler_001, handler_002, etc.) can be any string ofcharacters that is recognized within system 100 as identifying the RFcommand handler, e.g., an index, a name, or a memory pointer (e.g., anaddress). In some embodiments, the handler identifier is an address thatidentifies the location within memory (e.g., FRAM 234) where the handlersoftware is stored. At 312, the handler identifier can be used toreference or call the appropriate handler and the received RF command isexecuted. For example, RF stack 358 can perform a function call to thesoftware located at the handler identifier address which will then runand execute the received RF command. This is shown conceptually in FIG.3B with arrow 357.

In this embodiment, lookup data structure 370 only contains the RFcommand identifiers for those new RF command handlers 374 stored inwritable memory. Thus, if a match is not found within lookup datastructure 370 then RF stack 358 will look for the RF command identifierwithin ROM 230 at 314 (FIG. 3A), such as by referencing a second lookupdata structure stored within ROM 230. If the RF command identifier islocated within ROM 230, then the identifier for the original RF commandhandler 360 will be retrieved and that command handler 360 will becalled and/or used to execute the received RF command at 316. This isshown conceptually in FIG. 3B with arrow 359.

If a received RF command has separate handlers located within writablememory and ROM 230, then it is presumed that the handler located withinwritable memory is an upgraded or revised version and should be used toexecute the received RF command instead of the handler stored in ROM230. Thus, by referencing lookup data structure 370 stored in writablememory before referencing ROM 230, RF stack 358 will execute thereceived RF command with the handler identified within lookup datastructure 370 at which point the process will terminate, leaving theprior handler version in ROM 230 unused.

Lookup data structure 370 can also be configured to include the commandidentifier and handler identifier for every RF command, regardless ofwhere it is stored (e.g., FRAM 234, ROM 230, a hard disk, etc.). Such anapproach has the benefit of reducing the number of locations that RFstack 358 must refer to in order to locate the proper handler, forexample, RF stack 358 could avoid consulting a second lookup datastructure in ROM 230.

Instead of including handler identifiers, lookup data structure 370 caninstead include the handler software itself, at least for those RFcommands that have new RF command handlers. Such a configuration wouldallow RF stack 358 to avoid the need to decode a handler identifier orredirect to a separate location in memory where the handler code isstored.

The term “data structure” is used herein, such as with respect to thelookup data structure, to broadly refer to any organization of data insoftware or in hardware that enables the organized data to be referencedby the application software. Examples of data structures include, butare not limited to, an array, a set, a tree, a software table, asoftware list, a record, a database, an object, a union, a hardwarelookup table, or hardware lookup list. Lookup data structure 370 canalso be implemented as a sequence of software instructions (e.g., as oneor more software functions). It should be noted that, for ease ofillustration, lookup data structure 370 is depicted as a human readabletable in FIG. 4. Those of ordinary skill in the art will readilyrecognize that lookup data structure 370 would be implemented inmachine-readable formats in actual implementations.

A first configuration key (e.g., start) 401 and a second configurationkey (e.g., end) 403 can be included at the beginning and end of lookupdata structure 370, as depicted in FIG. 4, to identify the boundaries oflookup data structure 370. Configuration key 401 can also be used tonotify RF stack 358 whether any RF commands are present within lookupdata structure 370. If RF stack 358 is executed from ROM 230, then inmany embodiments RF stack 358 will automatically check lookup datastructure 370 for revisions or updates to the handlers, e.g., by using ajump function. However, it is possible that there may not be any new orrevised handlers identified within lookup data structure 370. Forinstance, in cases where the software code contained within ROM 230 wasrecently revised, there may not yet be a need to include further revisedor supplemental RF command handlers. Configuration key 401 can thereforeact as a flag telling RF stack 358 whether or not to reference lookupdata structure 370.

In an example embodiment, configuration key 401 has a firstpredetermined value, which can be in the same format as the command andhandler identifiers, e.g., 16 bit numbers. When RF stack 358 jumps tolookup data structure 370, it first checks the data contained within theconfiguration key 401 memory address to see if it matches the knownpredetermined code. If configuration key 401 does not match thepredetermined code, then RF stack 358 knows that lookup data structure370 is empty, or that there is otherwise no need to consult structure370, and RF stack 358 proceeds to identify the received RF command byreference to the identifiers and/or handlers contained within ROM 230.

If configuration key 401 matches the predetermined code, then RF stack358 can perform the comparison with the new RF command identifiers aspreviously explained. Configuration keys 401 and 403 preferably have thesame value, which is different than those of the RF command identifiers.After progressing through the RF command identifiers, when the samepredetermined code is read a second time RF stack 358 can realize thatthe second configuration key 403 has been reached indicating the end oflookup data structure 370. RF stack 358 can then reference the commandsand/or handlers contained within ROM 230. Different predetermined codescan be used for configuration keys 401 and 403 instead of using the samecodes.

Configuration key 403 and its location in lookup data structure 370 canalso be used to deactivate or otherwise prevent the execution of certainhandlers stored in writable memory. For example, during themanufacturing or factory programming process, it may be desirable to usecertain RF commands to cause sensor control device 102 to take actionsthat may assist in its own programming, debugging, or testing. Examplesof these “production” RF commands include, but are not limited to, thosethat instruct sensor control device 102 to report data read from memory(e.g., test program results, information confidential to themanufacturer, etc.), to write data (e.g., test patterns) or software(e.g., new handler software, etc.) to memory, and to execute a testroutine.

When sensor control device 102 is released from the manufacturer intothe marketplace, it may be desirable to disable these production RFcommands. In those embodiments, the command identifiers and the handleridentifiers (or handlers themselves) can be grouped together near thesequential end (or higher address locations) of lookup data structure370. This arrangement is depicted in FIG. 4B, where a group 410 ofproduction-only commands are placed near the end of lookup datastructure 370, with configuration key 403 located at the terminus oflookup data structure 370. Here, the “end” of lookup data structure 370corresponds to the address(es) or memory location(s) that would be readlast as the application software proceeds through lookup data structure370, and the end-most address could be a numerically higher or loweraddress number as compared to the beginning of lookup data structure370.

After production or manufacturing of sensor control device 102 iscomplete, disabling of these production RF commands can be achieved bywriting configuration key 403 into a location 412 that would be readbefore group 410 as shown in FIG. 4C. As the application software readsthrough lookup data structure 370 it will interpret location 412 as theend of structure 370 and will not execute the RF command handlerscontained in group 410, thereby preventing the execution of thosecommands from the writable memory while the device is in use in thefield.

If the production RF commands are supported in the ROM, the productionRF commands could still be executed from the ROM locations. In such anembodiment, the movement of configuration key 403 would only preventexecution of the RF command in whatever modified form is stored withinthe writable memory.

In alternative embodiments, multiple configuration keys 403 can be usedto delineate group 410, such as by placement of a first configurationkey 403 immediately before group 410 and a second configuration keyimmediately after group 410 (e.g., at the actual terminus of lookup datastructure 370). In a production setting, the application software can beprogrammed to ignore the first configuration key 403 and to treat thesecond configuration key 403 as a the actual terminus. But during actualuse by the user (e.g., in the field), the application software can beprogrammed to treat the incidence of the first configuration key 403 asthe effective terminus of lookup data structure 370.

Also provided herein are methods of manufacturing a sensor controldevice 102. FIG. 5 is a flow diagram depicting an example embodiment ofone such method 500. At 502, one or more semiconductor chips having aROM with software hardcoded therein are produced. At 504, the one ormore semiconductor chips are assembled onto a PCB in a configurationwhere writable non-volatile memory resident within the one or more chipsis not directly accessible, i.e., the memory bus and control signalleads are not present at an externally accessible interface. Then, at506, one or more new RF command handlers and a lookup data structure arewritten to the writable non-volatile memory using an indirect accesschannel.

In one example embodiment, the indirect access channel is serialinterface 229 (e.g., a boundary scan interface) that provides access tothe memory bus and control signals for the writable non-volatile memory.In this embodiment, the new RF command handlers and lookup datastructure are serially loaded into the serial interface and iterativelyloaded into the memory so that they are available to be used for RFcommand execution, such as in embodiments of method 300 describedherein.

In another example embodiment, the indirect access channel is an RFinterface through communication circuitry 258. Here, the new RF commandhandlers and lookup data structure are transmitted over an RF wavelengthto communication circuitry 258, which receives them and routes them toprocessor 256, or another programming unit, which can then write thereceived RF handlers and data structure to writable non-volatile memory.

The embodiments described herein can be integrated with analytemonitoring systems that function non-invasively, such as with the use ofinfrared (IR) energy, which does not require inserting a sensor deviceinto biological matter while that matter is within the body. Theembodiments described herein can also be integrated with analytemonitoring systems that utilize iontophoresis, such as in a non-invasivemanner.

Generally, embodiments of the present disclosure are used with in vivosystems, devices, and methods for detecting at least one analyte, suchas glucose, in body fluid (e.g., transcutaneously, subcutaneously withinthe ISF or blood, or within the dermal fluid of the dermal layer). Invivo analyte monitoring systems can be differentiated from “in vitro”systems that contact a biological sample outside of the body (or rather“ex vivo”) and that typically include a meter device that has a port forreceiving an analyte test strip carrying the biological sample of theuser, which can be analyzed to determine the user's blood sugar level.Many in vitro systems require a “finger stick” to obtain the biologicalsample. In vivo analyte monitoring systems, however, can operate withoutthe need for finger stick calibration.

Many embodiments include in vivo analyte sensors arranged so that atleast a portion of the sensor is positioned in the body of a user toobtain information about at least one analyte of the body. However, theembodiments described herein can be used with in vivo analyte monitoringsystems that incorporate in vitro capability, as well has purely invitro or ex vivo analyte monitoring systems. Furthermore, theembodiments described herein can be used in systems, devices, andmethods outside of the analyte monitoring field, either in other medicaldevice fields, or any other field that requires the supply of power toone device from another.

All features, elements, components, functions, and steps described withrespect to any embodiment provided herein are intended to be freelycombinable and substitutable with those from any other embodiment. If acertain feature, element, component, function, or step is described withrespect to only one embodiment, then it should be understood that thatfeature, element, component, function, or step can be used with everyother embodiment described herein unless explicitly stated otherwise.This paragraph therefore serves as antecedent basis and written supportfor the introduction of claims, at any time, that combine features,elements, components, functions, and steps from different embodiments,or that substitute features, elements, components, functions, and stepsfrom one embodiment with those of another, even if the followingdescription does not explicitly state, in a particular instance, thatsuch combinations or substitutions are possible. Express recitation ofevery possible combination and substitution is overly burdensome,especially given that the permissibility of each and every suchcombination and substitution will be readily recognized by those ofordinary skill in the art upon reading this description.

In many instances entities are described herein as being coupled toother entities. It should be understood that the terms “coupled” and“connected” (or any of their forms) are used interchangeably herein and,in both cases, are generic to the direct coupling of two entities(without any non-negligible (e.g., parasitic) intervening entities) andthe indirect coupling of two entities (with one or more non-negligibleintervening entities). Where entities are shown as being directlycoupled together, or described as coupled together without descriptionof any intervening entity, it should be understood that those entitiescan be indirectly coupled together as well unless the context clearlydictates otherwise.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

While the embodiments are susceptible to various modifications andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that these embodiments are not to be limited to the particularform disclosed, but to the contrary, these embodiments are to cover allmodifications, equivalents, and alternatives falling within the spiritof the disclosure. Furthermore, any features, functions, steps, orelements of the embodiments may be recited in or added to the claims, aswell as negative limitations that define the inventive scope of theclaims by features, functions, steps, or elements that are not withinthat scope.

1.-41. (canceled)
 42. An analyte monitoring device, comprising: aprocessor configured to execute application software; and non-transitorycomputer readable media, including: a non-transitory read-only memory(ROM) with a permanently coded memory layout, the ROM having a firstcommand handler stored therein, wherein the first command handler iscapable of executing a first RF command; a non-transitory writablememory having a lookup data structure stored therein, wherein thenon-transitory writable memory has a second command handler storedtherein, wherein the second command handler is a replacement commandhandler for the first command handler and is capable of executing asecond RF command; and wherein the non-transitory computer readablemedia comprises a program that, when executed by the processor, causesthe processor to: determine whether a received RF command is to beexecuted by the second command handler stored in the non-transitorywritable memory or by the first command handler stored in the ROM basedat least in part by reference to the received RF command in the lookupdata structure.
 43. The device of claim 42, wherein the lookup datastructure comprises an identifier for the second command handler and anidentifier for the second RF command that is executable by the secondcommand handler.
 44. The device of claim 43, wherein the analytemonitoring device is programmed to execute the received RF command withthe second command handler if an identifier for the received RF commandis located in the lookup data structure and is associated with theidentifier for the second command handler.
 45. The device of claim 44,wherein the identifier for the second command handler is a memorypointer.
 46. The device of claim 44, wherein the identifier for thesecond command handler is capable of executing a new RF command notexecutable by the first command handler.
 47. The device of claim 42,wherein the processor is further programmed to execute the received RFcommand with the second command handler
 48. The device of claim 42,wherein the analyte monitoring device further comprises a serialinterface and wherein the second command handler and the lookup datastructure are input into the writable memory through the serialinterface.
 49. The device of claim 48, wherein the analyte monitoringdevice further comprises a boundary scan architecture, and wherein theserial interface provides access to the boundary scan architecture. 50.The device of claim 48, wherein the writable memory comprises a memoryinput/output (I/O) bus that provides read and write access to thememory, wherein the serial interface is directly externally accessibleand the memory I/O bus is not directly externally accessible.
 51. Thedevice of claim 42, wherein the analyte monitoring device furthercomprises radio frequency (RF) communication circuitry adapted toreceive the RF command over an RF communication path, and wherein thesecond command handler and the lookup data structure are input into thewritable memory using the RF communication circuitry.
 52. An analytemonitoring device, comprising: a processor configured to executeapplication software; and non-transitory computer readable media,including: a non-transitory read-only memory (ROM) with a permanentlycoded memory layout, the ROM having a first command handler storedtherein, wherein the first command handlers is capable of executing afirst RF command; a non-transitory writable memory having a lookup datastructure stored therein, wherein the non-transitory writable memory hasa second command handler stored therein, wherein the second commandhandler is a replacement command handler that is capable of executing asecond RF command; and wherein the non-transitory computer readablemedia comprises a program that, when executed by the processor, causesthe processor to: determine an appropriate command handler with which toexecute the received RF command from among the first command handler andthe second command handler, at least in part by referencing the RFcommand in the lookup data structure; and execute the received RFcommand with the appropriate command handler.
 53. The device of claim52, wherein the writable memory is non-volatile writable memory.
 54. Thedevice of claim 52, wherein the lookup data structure comprises acommand identifier for the second RF command and a handler identifierfor the second command handler, wherein the command identifier for thesecond RF command is associated with the handler identifier for thesecond command handler in the lookup data structure.
 55. The device ofclaim 54, wherein the appropriate command handler is determined to bethe second command handler if a command identifier for the received RFcommand matches the command identifier for the second RF command. 56.The device of claim 55, wherein the appropriate command handler isdetermined to be the first command handler if the lookup data structuredoes not contain a command identifier for the received RF command. 57.The device of claim 54, wherein the lookup data structure includes aplurality of command identifiers and a plurality of handler identifiersfor a plurality of command handlers, each of the plurality of commandidentifiers being associated with one of the plurality of handleridentifiers.
 58. The device of claim 54, wherein the handler identifierfor the second command handler is a memory pointer.
 59. The device ofclaim 52, wherein the appropriate command handler is determined to bethe first command handler if an end of the lookup data structure is readwithout reading a command identifier for the received RF command. 60.The device of claim 52, wherein the analyte monitoring device is an invivo analyte monitoring system, the analyte monitoring device comprisinga patch for coupling the analyte monitoring device to the skin of a userand a sensor adapted for insertion through the user's skin.
 61. Thedevice of claim 60, wherein the processor is programmed to execute thereceived RF command with the appropriate command handler after thesensor has been inserted through the user's skin and while positioned inthe skin.